UK Life Sciences Council issues joint statement on HealthTech regulatory reform

The Life Sciences Council of the United Kingdom (UK) has today published a joint statement on a new agreement with other stakeholders, including UK industry representatives, to “accelerate the delivery of the future UK HealthTech regulatory system”.

The statement, copy available from here, explains that “The reform of the UK’s Medical Device regulation offers a golden opportunity to drive innovation and growth in the UK’s Life Science sector while ensuring patient safety remains at the heart of the regulatory approach”.

An advisory group has therefore been formed to “drive the delivery of the ambition of the Life Sciences Vision to have a best in class regulatory system”. Fine words indeed – we will have to wait and see whether the actions and deliverables match up.

The advisory group has already agreed on three priority areas:

• International recognition
• Routes for innovation, and
• System capacity

Initial proposals are promised for February 2023 and may include such things as e-labelling and recognition of “other trusted jurisdictions, such as the US” to help reduce the regulatory burden on industry (is the EU a trusted jurisdiction, I wonder? And if reducing the regulatory burden was really a priority, why not stick with the CE mark?).

The statement advises that “The MHRA will also publish a comprehensive UK roadmap of activities, milestones and timelines to deliver the required regulatory infrastructure. Any timelines will ensure sufficient time to allow the regulators and industry to prepare.”

The UK MedTech industry association ABHI will collate industry input and provide additional industry expertise to the advisory group and MHRA.